Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System
Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System
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DOI：
10.1016/j.jadohealth.2017.08.004
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发表时间：
2017-11-01
影响因子：
7.6
通讯作者：
Cano, Maria
中科院分区：
文献类型：
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作者：
Arana, Jorge;Mba-Jonas, Adamma;Cano, Maria
目的：人乳头瘤病毒 (HPV) 疫苗接种可预防导致某些癌症的 HPV 病毒株感染。 HPV 疫苗接种后出现体位性心动过速综合征 (POTS) 的报告引起了安全担忧。我们审查了提交给疫苗不良事件报告系统 (VAERS) 的 POTS 报告。方法：我们在 VAERS 数据库中检索了 2006 年 6 月至 2015 年 8 月期间任何类型 HPV 疫苗接种（二价、四价或九价）后发生 POTS 的报告。我们审查了报告并应用了既定的 POTS 诊断标准。我们根据分布的 HPV 疫苗剂量计算了未经调整的 POTS 病例报告率，并进行了经验贝叶斯数据挖掘，以筛查 HPV 疫苗接种后 POTS 报告的不成比例。结果：在 HPV 疫苗接种后的 40,735 份 VAERS 报告中，我们确定了 29 份完全符合诊断标准的 POTS 报告。其中，27 例 (93.1%) 为女性，平均年龄为 14 岁（范围 12-32 岁）。从接种疫苗到出现症状的中位时间为 43 天（范围 0-407）；大多数（18 例，75.0%）在 0 至 90 天内发病。经常报告的伴随症状包括头痛（22 例，75.9%）和头晕（21 例，72.4%）。 20 份报告 (68.9%) 记录了既往病史，其中最常见的是慢性疲劳 (5 份， 17.2%)、哮喘 (4 份， 13.8%) 和慢性头痛 (3 份， 10.3%)。美国每分发 650 万剂 HPV 疫苗，就会报告大约 1 例 POTS 病例。未检测到 POTS 和 HPV 疫苗接种的经验贝叶斯数据挖掘安全信号。结论：HPV 疫苗接种后很少报告 POTS。我们的审查没有发现任何异常或意外的报告模式表明存在安全问题。由爱思唯尔公司代表青少年健康与医学协会出版。
Purpose: Human papillomavirus (HPV) vaccination prevents infections with HPV strains that cause certain cancers. Reports of postural orthostatic tachycardia syndrome (POTS) following HPV vaccination have raised safety concerns. We reviewed POTS reports submitted to the Vaccine Adverse Event Reporting System (VAERS).Methods: We searched the VAERS database for reports of POTS following any type of HPV vaccination (bivalent, quadrivalent, or nonavalent) from June 2006 to August 2015. We reviewed reports and applied established POTS diagnostic criteria. We calculated unadjusted POTS case reporting rates based on HPV vaccine doses distributed and conducted empirical Bayesian data mining to screen for disproportional reporting of POTS following HPV vaccination.Results: Among 40,735 VAERS reports following HPV vaccination, we identified 29 POTS reports that fully met diagnostic criteria. Of these, 27 (93.1%) were in females and mean age was 14 years (range 12-32). Median time from vaccination to start of symptoms was 43 days (range 0-407); most (18, 75.0%) had onset between 0 and 90 days. Symptoms frequently reported concomitantly included headache (22, 75.9%) and dizziness (21, 72.4%). Twenty (68.9%) reports documented a history of pre-existing medical conditions, of which chronic fatigue (5, 17.2%), asthma (4, 13.8%), and chronic headache (3, 10.3%) were most common. Approximately one POTS case is reported for every 6.5 million HPV vaccine doses distributed in the United States. No empirical Bayesian data mining safety signals for POTS and HPV vaccination were detected.Conclusions: POTS is rarely reported following HPV vaccination. Our review did not detect any unusual or unexpected reporting patterns that would suggest a safety problem. Published by Elsevier Inc. on behalf of Society for Adolescent Health and Medicine.